Europe — EMA
Nintedanib
GNH USA supplies Nintedanib (Nintedanib), a tyrosine kinase inhibitor for idiopathic pulmonary fibrosis, systemic sclerosis‑associated interstitial lung
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What is Nintedanib?
Nintedanib, the active ingredient in Nintedanib, is a tyrosine kinase inhibitor presented as a unknown/oral tablet for oral use. It treats idiopathic pulmonary fibrosis, systemic sclerosis‑associated interstitial lung disease, and non‑small cell lung cancer when used with docetaxel. GNH USA supplies Nintedanib as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres and pharmacies worldwide.
What is Nintedanib used for?
Nintedanib is indicated for several fibrotic and oncologic conditions where inhibition of multiple growth factor receptors is therapeutic.
- Idiopathic pulmonary fibrosis: slows disease progression and reduces decline in lung function. - Systemic sclerosis‑associated interstitial lung disease: improves pulmonary function and delays worsening. - Non‑small cell lung cancer (in combination with docetaxel): enhances overall response rate and survival in previously treated patients.
What are the side effects of Nintedanib?
Nintedanib is associated with a range of adverse reactions that vary in frequency and severity.
Common Side Effects: - Diarrhea: frequent, watery stools that may require supportive care. - Nausea and vomiting: mild to moderate gastrointestinal upset. - Decreased appetite: reduced food intake leading to weight loss. - Elevated liver enzymes: transient increases in ALT/AST. - Abdominal pain: discomfort in the upper abdomen.
Serious or Rare Side Effects: - Severe liver injury: jaundice, hepatic failure requiring monitoring. - Bleeding events: gastrointestinal or pulmonary hemorrhage, especially with anticoagulants. - Arterial thromboembolism: risk of heart attack or stroke. - Gastrointestinal perforation: rare but potentially life‑threatening. - Severe infections: opportunistic infections in immunocompromised patients.
What precautions apply to Nintedanib?
Before initiating therapy, clinicians should assess baseline organ function and potential risk factors.
- Liver function monitoring: check ALT/AST before and during treatment. - Bleeding risk assessment: evaluate concomitant anticoagulant or antiplatelet use. - Cardiovascular evaluation: consider history of arterial thromboembolism. - Gastrointestinal caution: avoid in patients with active ulcers or recent perforation. - Pregnancy and lactation: avoid use due to unknown safety profile. - Store at room temperature: keep in the original packaging, protect from moisture and direct sunlight.
What does Nintedanib interact with?
Nintedanib may interact with other medicines that affect its metabolism or increase bleeding risk.
Major Interactions (Avoid): - Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin): may raise nintedanib exposure. - Strong CYP3A4 inducers (e.g., rifampicin, carbamazepine): may reduce efficacy. - Anticoagulants (e.g., warfarin) and antiplatelet agents: increase risk of serious bleeding.
Moderate Interactions (Monitor Closely): - P‑glycoprotein inhibitors (e.g., verapamil): may modestly increase plasma levels. - Non‑steroidal anti‑inflammatory drugs (NSAIDs): add to gastrointestinal bleeding risk. - Other anti‑angiogenic agents: potential additive toxicity on vascular endothelium.



